# US 10,864,295 B2 · Polymeric spinal fusion system including spinal cage

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- Number: US 10,864,295 B2
- Document ID: US10864295B2
- Status: Granted
- Kind: B2
- Application number: 15/574,542
- Filed: 2016-05-19
- Published: 2018-05-31
- Granted: 2020-12-15
- Earliest claimed: 2015-05-19
- Assignees: Shpp Global Technologies B.V.
- Applicants: SABIC Global Technologies B.V.
- Inventors: Lynn Colucci-Mizenko; Andrew Kugler
- Web page: https://patentgrep.com/patent/US10864295B2

## CPC

- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61F 2/4455: {for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages (intervertebral discs A61F2/442)}
- A61L 27/443: {with carbon fillers}
- A61L 27/446: {with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- C08G 73/1071: {Wholly aromatic polyimides containing oxygen in the form of ether bonds in the main chain}
- C08L 79/08: Polyimides; Polyester-imides; Polyamide-imides; Polyamide acids or similar polyimide precursors
- A61F 2/30749: {Fixation appliances for connecting prostheses to the body}
- A61F 2002/30153: {rectangular}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/30772: {Apertures or holes, e.g. of circular cross section}
- A61F 2002/3093: {for promoting ingrowth of bone tissue}
- A61F 2310/00011: Metals or alloys
- A61F 2310/00179: Ceramics or ceramic-like structures
- A61F 2310/00796: Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2430/38: for reconstruction of the spine, vertebrae or intervertebral discs
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- C08G: MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
- C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06)

## Abstract

A spinal cage for implantation between two adjacent vertebrae includes a polymer composition that includes a polyetherimide. The polyetherimide includes repeating units of the formula

## Claims

### Claim 1

A spinal cage for implantation between two adjacent vertebrae, wherein the spinal cage comprises a polymer composition, the polymer composition comprising a polyetherimide, wherein the polyetherimide comprises repeating units of the formula
wherein R is a divalent radical of the formula
or combinations thereof wherein Q is selected from —O—, —S—, —C(O)—, —SO2—, —SO—, and —CyH2y— wherein y is an integer from 1 to 5; and T is —O— or a group of the formula —O—Z—O— wherein the divalent bonds of the —O— or the —O—Z—O— group are in the 3,3′, 3,4′, 4,3′, or the 4,4′ positions and Z is a divalent group of the formula
wherein Q2 is selected from —O—, —S—, —C(O)—, —SO2—, —SO—, and —CyH2y— wherein y is an integer from 1 to 5.

### Claim 2 (depends on 1)

The spinal cage of claim 1, wherein the polyetherimide comprises structural units derived from at least one diamine selected from 1,3-diaminobenzene, 1,4-diaminobenzene, 4,4′-diaminodiphenyl sulfone, oxydianiline, 1,3-bis(4-aminophenoxy)benzene, or combinations thereof.

### Claim 3 (depends on 1)

The spinal cage of claim 1, wherein the polyetherimide has a weight average molecular weight of at least about 10,000 to about 150,000 grams per mole (g/mol).

### Claim 4 (depends on 1)

The spinal cage of claim 1, wherein the polyetherimide has less than 100 ppm amine end groups.

### Claim 5 (depends on 1)

The spinal cage of claim 1, further comprising a biocide, wherein the biocide is selected from germicides, antimicrobials, antibiotics, antibacterials, antiyeasts, antialgals, antivirals, antifungals, antiprotozoals, antiparasites, and combinations thereof.

### Claim 6 (depends on 1)

The medical device of claim 1, wherein the spinal cage comprises a polymer component comprising between 40 wt % and 90 wt % of the polyetherimide resin and between 10 wt % and 60 wt % of a filler by weight of the polymer component.

### Claim 7 (depends on 6)

The medical device of claim 6, wherein the filler comprises glass, carbon, carbon fiber, or a combination thereof.

### Claim 8 (depends on 1)

The spinal cage of claim 1, wherein the polymer composition further comprises ceramic or metal.

### Claim 9 (depends on 1)

The spinal cage of claim 1, wherein the spinal cage is sterilized using at least one sterilization process selected from the group consisting of: steam autoclave sterilization, hydrogen peroxide sterilization, gamma-ray sterilization and ethylene oxide sterilization.

### Claim 10 (depends on 1)

The spinal cage of claim 1, wherein the spinal cage has a compressive strength after sterilization that is within 5% of the compressive strength of the spinal cage prior to sterilization.

### Claim 11

A spinal fusion system comprising: a spinal cage and a plate, wherein the plate secures the spinal cage to the vertebrae, wherein the spinal cage comprises a polymer composition, the polymer composition comprising a polyetherimide, wherein the polyetherimide comprises repeating units of the formula
wherein R is a divalent radical of the formula
or combinations thereof wherein Q is selected from —O—, —S—, —C(O)—, —SO2—, —SO—, and —CyH2y— wherein y is an integer from 1 to 5; and T is —O— or a group of the formula —O—Z—O— wherein the divalent bonds of the —O— or the —O—Z—O— group are in the 3,3′, 3,4′, 4,3′, or the 4,4′ positions and Z is a divalent group of the formula
wherein Q2 is selected from —O—, —S—, —C(O)—, —SO2—, —SO—, and —CyH2y— wherein y is an integer from 1 to 5.

### Claim 12 (depends on 11)

The spinal fusion system of claim 11, wherein the plate comprises polyetherimide.

### Claim 13

A method of treating a spine of a patient comprising: removing a damaged spinal disk and inserting a spinal cage into an area of the spine that contained the damaged spinal disk, wherein the spinal cage comprises a polymer composition comprising a polyetherimide,
wherein the polyetherimide comprises repeating units of the formula
wherein R is a divalent radical of the formula
or combinations thereof wherein Q is selected from —O—, —S—, —C(O)—, —SO2—, —SO—, and —CyH2y— wherein y is an integer from 1 to 5; and T is —O— or a group of the formula —O—Z—O— wherein the divalent bonds of the —O— or the —O—Z—O— group are in the 3,3′, 3,4′, 4,3′, or the 4,4′ positions and Z is a divalent group of the formula
wherein Q2 is selected from —O—, —S—, —C(O)—, —SO2—, —SO—, and —CyH2y— wherein y is an integer from 1 to 5.

### Claim 14 (depends on 13)

The method of claim 13, wherein the polyetherimide has a weight average molecular weight of at least about 10,000 to about 150,000 grams per mole (g/mol).

### Claim 15 (depends on 13)

The method of claim 13, wherein the polyetherimide has less than 100 ppm amine end groups.

### Claim 16 (depends on 13)

The method of claim 13, further comprising a biocide, wherein the biocide is selected from germicides, antimicrobials, antibiotics, antibacterials, antiyeasts, antialgals, antivirals, antifungals, antiprotozoals, antiparasites, and combinations thereof.

### Claim 17 (depends on 13)

The method of claim 13, wherein the spinal cage comprises a polymer component comprising between 40 wt % and 90 wt % of the polyetherimide and between 10 wt % and 60 wt % of a filler by weight of the polymer component.

### Claim 18 (depends on 17)

The method of claim 17, wherein the filler comprises glass, carbon, carbon fiber, or a combination thereof.

### Claim 19 (depends on 13)

The method of claim 13, wherein the polymer composition further comprises ceramic or metal.